FDA Rejects Depomed’s Gabapentin for Menopausal Symptoms
- Posted by: Ken Phelps
- Published on: June 3, 2013
FDA concurred with its Advisory Committee’s recommendations and has turned down Depomed’s application seeking a new indication for gabapentin. Depomed has sought approval to use the drug in the treatment of menopausal symptoms – ‘hot flashes’. We reviewed the Advisory Committee’s deliberations in this blog this past April. The drug failed to show superiority over placebo. Depomed issued a press release confirming the news and indicated it would cease all further development efforts for this indication.